JDZ — Mixer, Cement, For Clinical Use Class I

FDA Device Classification

Classification Details

Product Code
JDZ
Device Class
Class I
Regulation Number
888.4210
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K934253exactechEXACTECH ALL POLY ACETABULAR CUPApril 29, 1994
K925025depuyPRISM BONE CEMENT MIXING SYSTEMJanuary 5, 1994
K912190strykerSTRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYSTAugust 29, 1991
K892937dentsply intlREUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTSJune 22, 1989
K861086zimmerZIMMER VACUUM MIXING SYSTEMApril 14, 1986
K854077strykerMIX EVAC IIJanuary 31, 1986
K853310howmedicaSIMPLEX ENHANCEMENT MIXERSeptember 11, 1985
K851205biodynamic technologiesCEMENTRIFUGEJuly 16, 1985
K843219zimmerZIMMER BONE CEMENT CENTRIFUGATION SYSNovember 29, 1984
K792186howmedicaHOWMEDICA MIX-KIT IIDecember 5, 1979
K780857howmedicaMIXING BOWL & SPATULA, DISPOSABLEJune 13, 1978
K760617strykerMIX EVAC BONE CEMENTOctober 5, 1976
K760636diemoldingORTHOMIXOctober 5, 1976